title: Immunogenicity and safety after booster vaccination of diphtheria, tetanus, and acellular pertussis in young adults: an open randomized controlled trial in Japan.
abstract: The recent increase of pertussis in young adults in Japan is hypothesized to be due in part to waning protection from the acellular pertussis vaccine. While a booster immunization may prevent an epidemic of pertussis among these young adults, little is known about the safety and immunogenicity of such a booster with the diphtheria, tetanus, and acellular pertussis vaccine (DTaP), which is currently available in Japan. One hundred and eleven medical students with a mean age of 19.4 years were randomly divided into 2 groups of 55 and 56 subjects and received, respectively, 0.2 or 0.5 ml of DTaP. Immunogenicity was assessed by performing the immunoassay using serum, and the geometric mean concentration (GMC), GMC ratio (GMCR), seropositive rate, and booster response rate were calculated. Adverse reactions and adverse events were monitored for 7 days after vaccination. After booster vaccination in the two groups, significant increases were found in the antibodies against pertussis toxin, filamentous hemagglutinin, diphtheria toxoid, and tetanus toxoid, and the booster response rates for all subjects reached 100%. The GMCs and GMCRs against all antigens were significantly higher in the 0.5-ml group than in the 0.2-ml group. No serious adverse events were observed. Frequencies of local reactions were similar in the 2 groups, although the frequency of severe local swelling was significantly higher in the 0.5-ml group. These data support the acceptability of booster immunization using both 0.2 and 0.5 ml of DTaP for young adults for controlling pertussis. (This study was registered at UMIN-CTR under registration number UMIN000010672.).
authors.affiliation: Department of Preventive Medicine, Faculty of Medicine, Saga University, Saga City, Japan.
authors.forename: Megumi
authors.initials: M
authors.lastname: Hara
authors.forename: Kenji
authors.initials: K
authors.lastname: Okada
authors.forename: Yuko
authors.initials: Y
authors.lastname: Yamaguchi
authors.forename: Shingo
authors.initials: S
authors.lastname: Uno
authors.forename: Yasuko
authors.initials: Y
authors.lastname: Otsuka
authors.forename: Chisato
authors.initials: C
authors.lastname: Shimanoe
authors.forename: Hinako
authors.initials: H
authors.lastname: Nanri
authors.forename: Mikako
authors.initials: M
authors.lastname: Horita
authors.forename: Iwata
authors.initials: I
authors.lastname: Ozaki
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Nishida
authors.forename: Keitaro
authors.initials: K
authors.lastname: Tanaka
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood*; D004165:Diphtheria / Q000276:immunology / Q000517:prevention & control; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000009:adverse effects* / Q000276:immunology* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007117:Immunization, Secondary / Q000009:adverse effects*; D007118:Immunoassay; D007564:Japan; D008297:Male; D012698:Serologic Tests; D013742:Tetanus / Q000276:immunology / Q000517:prevention & control; D014611:Vaccination; D022282:Vaccines, Acellular / Q000276:immunology; D014917:Whooping Cough / Q000276:immunology / Q000517:prevention & control; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022282:Vaccines, Acellular